In order to perform laparoscopic cholecystectomy safely and effectively, it is necessary for the surgeon to completely visualize the biliary tree. This is accomplished using, for example, a cholecystocholangiogram, in which a radio-opaque dye is injected into the cystic duct and the biliary tree anatomy is recorded via, for example, a cinefluorocholangiographic unit. In order to carry this out, a catheter must be inserted into the cystic duct to allow injection of the contrast fluid. Existing catheters do not optimize the ergonomics in such a way as to improve the speed and efficiency of the entire procedure significantly.
A major problem in carrying out successful cholangiographs is the safe introduction of the cholangiogram catheter into the duct. Additionally, there are frequently problems associated with maintaining the correct location of the catheter during the actual operation of the fluoroscope, during which time the operating staff leave the immediate vicinity of the patient. There are also dangers associated with inserting a relatively rigid and fixed geometry device into the duct, as at this initial state, the anatomy is not known. Neither is it known what obstructions might be present.
A device marketed by International Medical American Catheter has a fixed, rigid curvature at the end, which does not lend itself to atraumatic insertion into the duct, plus it has no means for locking it in position. A device marketed by Arrow Karlan also has a fixed curved end, but does incorporate a distal balloon to aid with retention during the actual fluoroscope operation. However, the device still has severe limitations. Other devices also have numerous deficiencies.